Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury

NCT05597176 | Completed DMC

• 1 other identifier: 20220652
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.

Conditions

Spinal Injuries

Outcome Measures

Primary Outcomes (4)

• Change in percent body fat

  Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)

  Baseline, 20 weeks (Post Intervention)

• Change in percent visceral fat

  Percent visceral fat will be assessed using DXA

  Baseline, 20 weeks (Post Intervention)

• Change in percent of lean body mass

  Percent lean body mass will be assessed using DXA

  Baseline, 20 weeks (Post Intervention)

• Change in percent of fat free mass

  Percent fat free mass will be assessed using DXA

  Baseline, 20 weeks (Post Intervention)

Secondary Outcomes (6)

• Change in Lipid Panel values

  Baseline, 20 weeks (Post Intervention)

• Change in resting metabolic rate

  Baseline, 20 weeks (Post Intervention)

• Change in glucose levels

  Baseline, 20 weeks (Post Intervention)

• Change in HgbA1C levels

  Baseline, 20 weeks (Post Intervention)

• Change in Insulin levels

  Baseline, 20 weeks (Post Intervention)

Study Arms (1)

Spinal Cord Injury Exercise Group

EXPERIMENTAL

Participants will exercise at home 3-5 times per week under supervision via teleconference. Participants will be part of this group for 18-20 weeks.

Other: Spinal Cord Injury Exercise Group

Interventions

Spinal Cord Injury Exercise Group OTHER

Participants will have an initial accommodation period of 4 weeks, during which four 10-minute exercise bouts/day will be interspersed with 5 minutes of rest. The bouts will gradually increase until at least continuous 40-minute sessions. The remaining 12-week intervention will be set at 70% max heart rate for a total of 16 weeks.

Spinal Cord Injury Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women of child-bearing potential who agree to refrain from getting pregnant during the trial
• Previously enrolled in the SCIENCE protocol (NCT03495986) randomized to the diet alone group in SCIENCE, and are willing to complete an 8-week (2 month) washout period after the completion of the dietary intervention in the study.

You may not qualify if:

• Those who have participated in a Functional Electrical Stimulation (FES) or ACE exercise program (\>60 minutes/week) within the past 3 months
• Self-reported or documented history of:
• orthopedic limitations
• coronary artery disease
• type 1 diabetes mellitus; insulin-requiring Type 2 diabetes mellitus; untreated Type 2 diabetes mellitus
• untreated hypothyroidism
• renal disease
• uncontrolled autonomic dysreflexia, recent (within 3 months)
• deep vein thrombosis (within the past 3 months)
• On anticoagulation therapy
• Pressure injuries \> Grade II
• Decisional impairment
• Prisoners
• Pregnant or nursing women
• Any potential causes of autonomic dysreflexia at the discretion of the PI

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Christine E. Lynn Rehabilitation Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Injuries

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries

Study Officials

• Eduard Tiozzo, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: January 13, 2023
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)